Scientific Opinion on the re-evaluation of cochineal, carminic acid, carmines (E 120) as a food additive

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Article
Panel on Food Additives and Nutrient Sources Added to Food
Acknowledgements

The Panel wishes to thank the members of the former Working Group ‘A’ Food Additives and Nutrient Sources (2011–2014) and the Standing Working Group on the re-evaluation of food colours: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Maria Jose Frutos, Pierre Galtier, David Gott, Claude Lambré, Jean-Charles Leblanc, Agneta Oskarsson, Jeanne Stadler, Paul Tobback, Ine Waalkens-Berendsen and Rudolf Antonius Woutersen, for the preparatory work on this scientific opinion and EFSA staff members Petra Gergelova, Ana Maria Rincon and Stavroula Tasiopoulou for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

EFSA Journal
EFSA Journal 2015;13(11):4288 [66 pp.].
doi
10.2903/j.efsa.2015.4288
Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Younes Maged.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00360
Adopted
27 October 2015
Published
18 November 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Cochineal, carminic acid, carmines (E 120) have been previously evaluated by JECFA and by the SCF. Both committees established an ADI of 5 mg/kg bw/day. The Panel noted that the title of the EC specifications for E 120 does not adequately correspond to the specified food additive and therefore, proposes to modify it to “E 120 cochineal extract, carminic acid and carmines”, which would more accurately reflect the material used. The Panel also noted that the specifications need to be updated with regard to the maximum limits for certain toxic elements present as impurities, to ensure that E 120 will not be a significant source of exposure to these toxic elements in food. No ADME studies on cochineal extract, carminic acid or carmines were available for evaluation, but indirect evidence suggests that carmines are absorbed and distributed in the body. Acute, short-term, subchronic, carcinogenicity, reproduction and developmental toxicity studies conducted in rats or mice did not show toxicological potential. Consideration of the available information regarding genotoxicity indicated that carminic acid is not genotoxic. The Panel concluded that the present dataset does not give reason to revise the ADI of 5 mg carmine (containing approximately 50 % carminic acid)/kg bw, allocated by the SCF in 1983. The Panel concluded that this ADI should be expressed as carminic acid content, which would correspond to 2.5 mg carminic acid/kg bw/day. The Panel considered that, since no threshold dose can be established for allergic reactions, it is advisable that exposure to the eliciting allergens, such as proteinaceous compounds, in E 120 is avoided by introducing appropriate purification steps in the manufacturing process. Refined exposure estimates show that exposure to E 120 for the non-brand-loyal scenario, is below the ADI of 2.5 mg carminic acid/kg bw/day for all population groups.

Keywords
Cochineal extract, carminic acid, carmines, E 120, CI Natural Red 4, INS No 120, 7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid
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Number of Pages
66